EPLERENONE BLUEFISH 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eplerenona Bluefish 50mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Eplerenona Bluefish and what is it used for.
2. What you need to know before you take Eplerenona Bluefish.
3. How to take Eplerenona Bluefish.
4. Possible side effects.
5. Storage of Eplerenona Bluefish.

1. Contents of the pack and further information.

1. What is Eplerenona Bluefish and what is it used for

Eplerenone belongs to a group of medicines known as selective aldosterone blockers. These blockers inhibit the action of aldosterone, a substance produced by the body that controls blood pressure and cardiac function. High levels of aldosterone can cause changes in your body that lead to heart failure.

Eplerenone is used to treat heart failure to prevent worsening and reduce hospitalization if you have:

1. a recent myocardial infarction, in combination with other medicines used to treat your heart failure or

1. mild persistent symptoms, despite the treatment you have been receiving so far.

2. What you need to know before you take Eplerenona Bluefish

Do not take Eplerenona Bluefish

• if you are allergic to eplerenone or any of the other ingredients of this medicine (listed in section 6),
• if you have high levels of potassium in your blood (hyperkalemia),
• if you are taking medicines that help your body get rid of excess fluid (potassium-sparing diuretics),
• if you have severe kidney problems,
• if you have severe liver problems,
• if you are taking medicines used to treat fungal infections (ketoconazole or itraconazole),
• if you are taking medicines used to treat HIV infection (nelfinavir or ritonavir),
• if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin),
• if you are taking nefazodone to treat depression,
• if you are taking medicines used to treat certain heart diseases or high blood pressure (such as ACE inhibitors and angiotensin receptor antagonists) at the same time.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Eplerenona Bluefish,

• if you have kidney or liver disease (see also “Do not take Eplerenona Bluefish”),
• if you are taking lithium (used to treat manic-depressive disorders, also called bipolar disorder),
• if you are taking tacrolimus or cyclosporin (used to treat skin diseases, such as psoriasis or eczema, and to prevent organ rejection after transplantation).

Children and adolescents

The safety and efficacy of eplerenone in children and adolescents have not been established.

Other medicines and Eplerenona Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines used to treat HIV), clarithromycin, telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression), as these medicines reduce the metabolism of Eplerenona Bluefish, and thus prolong its effect in the body.
• Potassium-sparing diuretics (medicines that help your body get rid of excess fluid) or potassium supplements (salt tablets), as these medicines increase the risk of high levels of potassium in the blood.
• ACE inhibitors and angiotensin receptor antagonists (used to treat high blood pressure, heart disease, or certain kidney diseases) at the same time, as these medicines may increase the risk of high levels of potassium in the blood.

• Lithium (used to treat manic-depressive disorders, also called bipolar disorder). The use of lithium with diuretics and ACE inhibitors has been shown to cause high levels of lithium in the blood, which can cause the following adverse reactions: loss of appetite, vision changes, fatigue, weakness, and muscle cramps.
• Cyclosporin or tacrolimus (used to treat skin diseases, such as psoriasis or eczema, and to prevent organ rejection after transplantation). These medicines can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• Non-steroidal anti-inflammatory medicines (NSAIDs - certain painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines can cause kidney problems and thus increase the risk of high levels of potassium in the blood.
• Trimethoprim (used to treat bacterial infections) may increase the risk of high levels of potassium in the blood.
• Alpha-1 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate diseases), may lead to a decrease in blood pressure and dizziness when standing up.
• Tricyclic antidepressants, such as amitriptyline or amoxapine (used to treat depression), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (used to treat psychiatric disorders), amifostine (used during cancer chemotherapy), and baclofen (used to treat muscle spasms). These medicines may lead to a decrease in blood pressure and dizziness when standing up.
• Corticosteroids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin diseases), and tetracosactide (used primarily to diagnose and treat adrenal cortex diseases), may reduce the blood pressure-lowering effect of Eplerenona Bluefish.
• Digoxin (used to treat heart diseases). Blood levels of digoxin may increase when taken with Eplerenona Bluefish.
• Warfarin (an anticoagulant medicine): Caution is required when administering warfarin doses because high levels of warfarin in the blood may affect the effect of Eplerenona Bluefish in the body.
• Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine used to treat HIV infections), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart problems and high blood pressure), as they reduce the metabolism of Eplerenona Bluefish, thus prolonging its effect in the body.
• Hypericum perforatum or St. John's Wort (a medicinal plant), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other things, to treat epilepsy), may increase the metabolism of Eplerenona Bluefish and thus reduce its effect.

Taking Eplerenona Bluefish with food and drinks

Eplerenona Bluefish can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The effect of Eplerenona Bluefish during pregnancy in humans has not been evaluated.

It is not known whether eplerenone is excreted in breast milk. Your doctor will decide with you whether to interrupt treatment or breast-feeding.

Driving and using machines

After taking Eplerenona Bluefish, you may feel dizzy. If this happens, do not drive or use machines.

Eplerenona Bluefish contains lactose

This medicine contains lactose monohydrate (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Eplerenona Bluefish contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 25 mg and 50 mg tablet; it is essentially “sodium-free”.

3. How to take Eplerenona Bluefish

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Eplerenone tablets can be taken with or without food. Swallow the tablets whole with plenty of water.

Eplerenone is usually given together with other medicines for heart failure, for example, beta-blockers. The usual initial dose is one 25 mg tablet once a day, increasing later after about 4 weeks to 50 mg daily (one 50 mg tablet or two 25 mg tablets). The maximum dose regimen is 50 mg per day.

Potassium blood levels should be determined before starting treatment with eplerenone, during the first week, and one month after starting treatment or after a dose change. Your doctor may adjust the dose based on your potassium blood levels.

Patients with kidney or liver problems

If you have mild kidney problems, you should start treatment with a 25 mg tablet per day, and if you have moderate kidney problems, you should start treatment with a 25 mg tablet every other day. These doses may be adjusted, if your doctor indicates, and according to your potassium blood levels. Eplerenone is not recommended in patients with severe kidney disease.

No initial dose adjustment is necessary in patients with mild to moderate liver problems. If you have any liver or kidney disease, it may be necessary to perform potassium blood level determinations more frequently (see also “Do not take Eplerenona Bluefish”).

Elderly patients

No initial dose adjustment is necessary in elderly patients.

Use in children and adolescents

Eplerenone is not recommended in children and adolescents.

If you take more Eplerenona Bluefish than you should

If you take more eplerenone than you should, inform your doctor or pharmacist immediately. If you have taken too much medicine, the most likely symptoms will be low blood pressure (manifested as dizziness, blurred vision, weakness, sudden loss of consciousness) or hyperkalemia, high levels of potassium in the blood (manifested by muscle cramps, diarrhea, nausea, dizziness, or headache).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eplerenona Bluefish

If it is almost time for your next dose, skip the dose you missed and take the next dose at the scheduled time. Otherwise, take the dose as soon as you remember, provided that more than 12 hours have passed since the scheduled time for the next dose. Go back to taking your medicine as you normally would. Do not take a double dose to make up for forgotten doses.

If you stop taking Eplerenona Bluefish

It is important to keep taking eplerenone as your doctor indicated, unless your doctor tells you to stop treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen:

Seek medical attention immediately,

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• blistering and difficulty breathing.

These are symptoms of angioedema, a rare side effect (may affect up to 1 in 100 people)

Other reported side effects include:

Common side effects(may affect up to 1 in 10 people):

• high levels of potassium in the blood (these symptoms include muscle cramps, diarrhea, nausea, dizziness, or headache),
• dizziness,
• fainting,
• high levels of cholesterol in the blood,
• insomnia (difficulty sleeping),
• headache,
• heart problems such as irregular heartbeat and heart failure,
• cough,
• constipation,
• low blood pressure,
• diarrhea,
• nausea,
• vomiting,
• abnormal kidney function,
• rash,
• itching,
• back pain,
• weakness,
• muscle spasms,
• increased levels of urea in the blood,
• increased levels of creatinine in the blood, which may indicate kidney problems.

Uncommon side effects(may affect up to 1 in 100 people):

• infection,
• eosinophilia (increase in certain white blood cells),
• low levels of sodium in the blood,
• dehydration,
• high levels of triglycerides (fats) in the blood,
• rapid heartbeat,
• inflammation of the gallbladder,
• drop in blood pressure that may cause dizziness when standing up,
• blood clots in the legs,
• sore throat,
• flatulence,
• underactive thyroid,
• increased blood sugar levels,
• decreased sense of touch,
• increased sweating,
• musculoskeletal pain,
• weakness and general malaise,
• kidney inflammation,
• breast enlargement in men,
• changes in certain blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eplerenona Bluefish

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Eplerenona Bluefish

• • The active substance is eplerenone. Each tablet contains 50 mg of eplerenone.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose (Type A), hypromellose (Benecel E3), talc, and magnesium stearate.

The coating of Eplerenona Bluefish 50 mg film-coated tablets contains macrogol/PEG 6000, HPMC 2910/Hypromellose 5cP, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of Eplerenona Bluefish and pack contents

Eplerenona Bluefish 50 mg film-coated tablets are presented as round, biconvex, yellow tablets, marked with "E50" on one side.

Eplerenona Bluefish film-coated tablets are presented in cardboard boxes with PVC opaque/Al white blisters containing 10, 20, 28, 30, 50, 90, 100, and 200 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Bluefish Pharmaceuticals AB

P.O.Box 49013

100 28 Stockholm

Sweden

Manufacturer

Pharmathen S.A.

Dervenakion 6, Pallini 15351, Attikis

Greece and Pharmathen International S.A.

Industrial Park Sapes Rodopi Perfecture, Block No. 5, Rodopi, 69300

Greece

Local Representative:

Bluefish Pharma S.L.U.,

AP 36007, 2832094 Madrid,

Sucursal 36

This medicine is authorised in the Member States of the EU with the following names:

Date of last revision of this leaflet: September 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es